In their single-minded venture of “producing” (shengchan, in their own word) the world’s first gene-edited babies, He Jiankui and his associates have posed numerous and daunting ethical challenges to China and the world. They can be mapped or identified through these four categories:

typical problems related to research ethics;

broader political, socio-cultural, and transcultural issues;

fundamental ethical questions on the use of gene editing in human reproduction itself; and

even more fundamental matters on the moral goals of science and technology.

Different levels of ethical issues should be explored in an interconnected and interdisciplinary approach, but it is important to note that ethical soundness on one dimension does not mean moral justification on any other level or dimension.

Some prominent U.S. scientists, including George Church at Harvard, have offered a defence of He’s human experimentation on two grounds. First, genetically editing humans can be ethically justifiable. Second, the international community and Chinese society are bullying He for having not done “the paperwork right.” Church says he feels “an obligation to be balanced” about He’s case. Some international and Chinese discussions about it have focused upon the ethics of procreating gene-edited humans. However, even if genetically modified reproduction would be ethical, He’s clinical trials have been conducted unethically. As bioethicists, we thus have an obligation to point out that Church’s defence amounts to what Chinese would say is “hunxiao shiting” (misleading people) and “hunxiao shifei” (confusing right and wrong).

A large number of good reasons support the spontaneous overwhelming Chinese and international denouncement of He’s research. In contrast to some stereotypical images of China in the West, He’s experiments have clearly defied Chinese academic standards, ethical guidelines, and procedures of biomedical research. Among others, in accordance with an international bioethical and governance consensus, the 2003 “Ethical Guiding Principles for the Research of Embryonic Stem Cell” issued by China’s Ministry of Science and Technology and then Ministry of Health (now National Health Commission) has unequivocally prohibited any research beyond the first 14 days of an embryo’s creation as well as any implantation of a genetically modified embryo into the human reproductive system.

It is not hard to see how scientific integrity has been tarnished. As Chinese people have quickly realized, the primary goals of He’s genetic experiments, conducted in secrecy and purposefully announced via YouTube on the eve of the Second International Summit on Human Genome Editing are not so much to advance science and relieve patients’ suffering, but to maximize sentimentalism, win fame, and, even worse, consolidate and expand his gene commodification.

Against what He himself has claimed, the aim of his experiments was not to treat any serious genetic disease. Rather, He sought to use the gene-editing tool CRISPR-Cas9 to create a 32-base pair deletion in the CCR5 gene, a genetic variant that confers increased resistance to HIV infection. However, the transmission of HIV to a child can be effectively prevented by other safer measures, such as washing the infected father’s sperm before in vitro fertilization—a step He’s team had in fact performed, which essentially eliminated any supposed “medical necessity” of the experiment at the outset. In addition, the truncated CCR5 variant may increase one’s susceptibility to other pathogens such as West Nile Virus. He’s “gene surgery” has therefore only posed a number of foreseeable and unforeseeable risks, to the babies themselves and their future progeny, without providing any obvious medical benefit.

He’s genetic misadventure also holds little scientific merit and reflects poorly designed experimentation. More than 100 Chinese scientists have instantly condemned He’s experiments for the precise reason that, although gene-editing of human embryos has been technically possible for some time now, this was a premature and poor application of the technology. Prudent scientists have chosen not to attempt such risky experimentation due to the pressing ethical considerations associated with germline editing. The only “innovation” or boldness that He and his associates have demonstrated is unscrupulous behavior and the willingness to cross a red ethical line set by international and Chinese consensus.

The data presented by He likewise suggests that his experiments failed to even achieve the proposed scientific aims. Slides from his presentation show that neither Lulu nor Nana possessed the 32-base pair deletion desired in the CCR5 gene, and each embryo instead expressed variants of various lengths. These novel mutations have not been previously shown to prevent HIV infection and may even be harmful. Some of He’s data also suggest the presence of both edited and unedited cells, leading to a phenomenon called mosaicism, as well as off-target effects of the edit that could cause other unanticipated changes in the genome.

The ethics approval process has been a joke or, at best, just “zou guochang” (doing it perfunctorily). The ethics application approval may have been faked. If indeed proved to be genuine, the approval by a private hospital was gravely insufficient regardless.

Informed consent of the research participants has obviously been violated. According to an investigative journalist’s report in a prestigious magazine in China, eight couples whose males have HIV/AIDS were drawn to the research because of the offer of IVF treatment (which would be otherwise prohibitively expensive) and other medical and financial inducement (which further evinces exploitation of one of this highly vulnerable population). Against international and Chinese ethical norms, the participants were not informed about risks to their children as well as the nature of the medical trial (the problem of misinformation or inadequate information). They were told, boldly and untruthfully, that their children would be healthy. After being pressed by the participants about what would be done if the children were born unhealthy, the researcher replied that they would “get rid of” (chulidiao) them. One of eight couples immediately dropped the clinical trial because the callous answer shocked them. For the couple, this is a matter of intentionally destroying human life.

Ironically, He’s research even profoundly contradicts his own expressed ethics. In February 2017, soon after attending a high-level but closed-door symposium on CRISPR technologies at the Cold Spring Harbor Laboratory, He published a short post in his personal blog on ScienceNet (Kexuewang), a global Chinese scientific community supported by China’s national academies of science and engineering. He clearly outlined the five widely acknowledged major risks involved: the limits of animal models, the danger of off-target effects, mosaicism, risks to embryonic and fetal development, and the possibly harm to future generations and the human gene pool. It concludes that “From both scientific and socio-ethical angles, any action to edit human germ cell line or make [sic] gene-edited humans is irresponsible.” (Italic added) Almost simultaneously with their public announcement on gene-edited babies, He and his team published an article on their “five ethical principles” for what they call “therapeutic assisted reproductive technologies” in The CRISPR Journal. Under the second principle “only for serious disease, not vanity,” they wrote: “Gene surgery exposes a child to potential safety risks that can be permanent. Performing gene surgery is only permissible when the risks of the procedure are outweighed by a serious medical need.”

He’s historic genetic misadventure constitutes a historic violation of scientific integrity and morality. The unethicalness is absolutely not just about “the paperwork.” Rather, one should marvel at He’s ethical, if not scientific, “genius.” For He and his associates have given the world a perfect paradigm case to demonstrate in most lively ways on how a scientific project can breach almost every ethical norm of biomedical research. Moreover, the epic scientific misconduct prompts studies of the complicated political and sociocultural context of gene-editing technologies and urges the examination of the fundamental moral matters regarding the application of science and technology in general. To address the challenges of human gene editing, it is imperative not only to reinforce established bioethical norms but also to advance a “new socio-bioethics” by moving beyond the mainstream largely individualistic modes of bioethical inquiries.

Jing-Bao Nie, BMed, BMed, MA, PhD, is a professor at the Bioethics Centre, University of Otago, New Zealand, and a Hastings Center Fellow. Alexander T.M. Cheung, BS, MBHL, studied at the University of Otago and is a computational biologist at the Broad Institute of MIT and Harvard.

#Bioethics News: In its decision to approve two drugs for orange and grapefruit trees, the E.P.A. largely ignored objections from the C.D.C. and the F.D.A., which fear that expanding their use in cash crops could fuel antibiotic resistance in humans. https://t.co/9hAvsohLvB